Regulatory Affairs Specialist

4 hours ago

Thoothukudi, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 8,00,000 - ₹ 15,00,000
Regulatory Affairs Specialist

We are seeking an experienced Regulatory Affairs Specialist to join our team. This key role will be responsible for preparing, reviewing, and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements.

The ideal candidate will have a strong understanding of global regulatory guidelines and dossier preparation, as well as excellent organizational and analytical skills. Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems is also essential.

  • Key Responsibilities:
  • Screen and analyze documents received for product registration requests as per country-specific guidelines.
  • Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
  • Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
  • Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
  • Arrange supportive batch-related documents (e.g., DOC, COA) for registration samples.
  • Manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments/invoices.
  • Support the Compliance team by providing updated documents required for technical file preparation.
  • Periodically review and update Technical Master Files to ensure consistency across product categories.
  • Coordinate with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.
  • Ensure timely preparation and submission of documents related to audit findings.
  • Adhere to departmental priorities and provide support for additional tasks as assigned.
Requirements
  • Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
  • 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
  • Strong understanding of global regulatory guidelines and dossier preparation.
  • Detail-oriented, with excellent organizational and analytical skills.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
  • Good written and verbal communication skills.
Skills Required
  • Knowledge of international regulatory requirements and guidelines.
  • Expertise in dossier compilation, review, and submission processes.
  • Ability to prepare and analyze technical and compliance-related documentation.
  • Familiarity with audit documentation and regulatory query management.
  • Document management and record-keeping skills.

As a valued member of our team, you will have the opportunity to work on challenging projects and develop your skills in regulatory affairs.

Our company is committed to diversity and inclusion, and we welcome applications from qualified candidates of all backgrounds.

Don't miss this exciting opportunity to join our dynamic team

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